Registration Dossier

Toxicological information

Endpoint summary

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Administrative data

Description of key information

Reliable substance-specific information concerning the toxicity for zinc difluoride does not exist. Instead, toxicological information on very soluble inorganic fluoride (mainly sodium fluoride) substances and very soluble inorganic zinc substances were extrapolated to zinc difluoride considering that systemic effects mainly based on the concentrations of the Zn2+ and F- ions, which are the key concern of zinc difluoride.

For read-across justification please refer to IUCLID section 7 "toxicological information" - "additional information" or to the report attached under IUCLID "0 category".

Sodium fluoride tested negative (i.e. not sensitising) in sensitisation studies according to Buehler (EPA OPP 81-6). Furthermore, there are no indications that a zinc substance causes skin sensitization in a guinea pig maximization test.

Positive human experience with zinc difluoride has not been reported. Based on read-across (see attachment on assessment entity), it is assumed that zinc difluoride does not possess a skin sensitisation potential.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

Zinc difluoride does not have a skin sensitisation potential and therefore must not be classified and labelled according to Regulation (EC) 1272/2008 and subsequent adaptations.